Catalog Number

19656

Brand Name

Biotone® Rational Block Plastic Posteriors

Version/Model Number

67P U 33M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 23, 2022

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

d7046b85-af44-4efe-a47f-aa9bbcc2015a

Public Version Date

May 24, 2022

Public Version Number

4

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-